Chronic Low Back Pain
Conditions
Keywords
Low Back Pain, Chronic Pain, Cognitive Behavioral Therapy, Primary Health Care, Physical Therapy
Brief summary
Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention (Back on Track intervention) in WPN3- classified patients, and to evaluate whether this Back on Track intervention results in a significant improvement in functional disability in this subgroup of patients.
Interventions
A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Sponsors
Adelante, Centre of Expertise in Rehabilitation and Audiology
The Province of Limburg
CZ Fonds
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months. * Presence of contributing social and psychological factors, however not complex (WPN3-classification). * Age between 18 and 65 year * Sufficient knowledge of the Dutch language * Acceptance towards the biopsychosocial approach instead of biomedical approach
Exclusion criteria
* Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome * Pregnancy * Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quebec Back Pain Disability Scale (QBPDS) | Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Credibility and Expectancy Questionnaire (CEQ) | Directly after the first treatment (in the first week of the intervention) | — |
| EuroQol-5D (EQ-5D) | Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Hospital Anxiety and Depression Scale (HADS) | Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Pain Catastrophizing Scale (PCS) | Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Numeric Rating Scale (NRS) | Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Tampa Scale of Kinesiophobia (TSK) | Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Global Perceived Effect (GPE) | Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P) | Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Social demographic questionnaire | pre-treatment (baseline) | — |
| Treatment satisfaction questionnaire | post-treatment (with an expected average of 8 weeks) | This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge |
| Pain Self-Efficacy Questionnaire (PSEQ) | Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up | — |
| Protocol adherence | All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months) | Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment. |
Countries
Netherlands
Outcome results
None listed